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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameHYALGAN(R)
Classification Nameacid, hyaluronic, intraarticular
Generic Nameacid, sodium hyaluronic
ApplicantFIDIA FARMACEUTICI SPA
PMA NumberP950027
Date Received07/28/1995
Decision Date05/28/1997
Product Code
MOZ[ Registered Establishments with MOZ ]
Docket Number 98M-0980
Notice Date 12/07/1998
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
The device is indicated for the treatment of pain in osteoarthritis (oa) of theknee in patients who have failed to respond adequately to conservative nonpharmacologic therapy, and to simple analgesics, e. G. , acetaminophen.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S006 S009 S010 S011 S012 
S014 
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